CompletedNCT02439983Updated Aug 3, 2016

Brain Imaging Study

An interventional study of Proprietary Nutritional Supplement and Placebo in Brain Health, sponsored by Pharmanex. Completed at 1 site in United States. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-03.

Sponsored by Pharmanex · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 68
Allocation: Randomized
Ages: 40 Years to 60 Years
Sex: All

Study summary

The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment.

Conditions studied

Brain Health

In context

Lead sponsor

Pharmanex is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Both male and female subjects will be included.
Age between 40-60 years inclusive.
Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
Eats 1 or fewer servings of fatty fish per week.
BMI \< 35

Exclusion criteria

Exclusion Criteria:

Current or past neurological illness.
Substance abuse or dependence within the prior 60 days.
Current depression (HAMD greater than 20) or anxiety disorder (HAMA greater than 18).
Current or past history of psychiatric disorder.
History of head trauma with loss of consciousness.
Contraindication to brain MRI examination.
Supplementation with Omega 3, fish oil, or other over the counter supplements including the other bioactive ingredients in the proprietary nutritional supplement, antioxidants and multi-vitamin mineral supplements for the previous 3 months.
Plasma Omega3 Index >5% at screening visit.
Subject has a known allergy or intolerance to any of the ingredients contained in the proprietary nutritional supplement or placebo.
Subject is currently pregnant, planning to become pregnant, or is breastfeeding.

Study design

Phase: Not applicable
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 68 participants (actual)

Study arms

Placebo comparator
Placebo
Dietary Supplement: Placebo
Experimental
Proprietary Nutritional Supplement
Dietary Supplement: Proprietary Nutritional Supplement

Interventions

Dietary supplementProprietary Nutritional Supplement
2 capsules taken by mouth with morning and evening meals.
Dietary supplementPlacebo
2 capsules taken by mouth with morning and evening meals.

What researchers measure

Primary outcomes

Change in MRI Brain scan
Determine differences in brain metabolism, brain connectivity, or brain structure. Highlight regional brain changes between pre and post chronic supplementation with a proprietary nutritional formula.
Time frame: Change from Baseline MRI Brain scan at Day 42

Secondary outcomes

Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)
Time frame: Change from Baseline anxiety at Day 42
Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)
Time frame: Change from Baseline depression at Day 42
Change in mood as measured by the Profile of Mood States (POMS)
Time frame: Change from Baseline mood at Day 42
Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV)
Time frame: Change from Baseline memory at Day 42
Change in fluency as measure by Letter and Category Fluency test
Time frame: Change from Baseline fluency at Day 42
Change in Chemistry panel
Time frame: Change from Baseline Chemistry panel at Day 42
Change in RBC fatty acid profile
Time frame: Change from Baseline RBC fatty acid profile at Day 42
Change in Gene expression
Time frame: Change from Baseline Gene expression at Day 42
Measurement of polyphenol metabolites in saliva
Time frame: Day 42

Study locations

1 site

University of Utah - Brain Institute
Salt Lake City, Utah 84108, United States

References and documents

Publications

Mastaloudis A, Sheth C, Hester SN, Wood SM, Prescot A, McGlade E, Renshaw PF, Yurgelun-Todd DA. Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women. Free Radic Biol Med. 2020 Jun;153:112-121. doi: 10.1016/j.freeradbiomed.2020.04.017. Epub 2020 Apr 23. PubMed 32335159 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02439983
Lead sponsor: Pharmanex
Collaborators: University of Utah
Responsible party: Sponsor
First posted: May 12, 2015
Start date: Apr 2015
Primary completion: Jun 2016
Completion: Jun 2016
Last update: Aug 3, 2016

Study contacts

Deborah Yurgelun-Todd, Ph.D.

principal investigator · University of Utah

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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